THOUSAND OAKS, Calif., June 8, 2012 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced top-line results of the Phase 3 EVOLVE™ (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial, which evaluated Sensipar®/Mimpara® (cinacalcet) for the reduction of the risk of mortality and cardiovascular (CV) events among 3,883 patients with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) receiving dialysis. The primary endpoint of the study was time to the composite event comprising all-cause mortality or first non-fatal cardiovascular event, including myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event. Although patients in the Sensipar/Mimpara arm experienced numerically fewer composite primary events, the results were not statistically significant, and the trial did not meet its primary endpoint in the intent-to-treat analysis.

"Amgen embarked on the EVOLVE trial to understand whether treating secondary HPT with Sensipar/Mimpara could positively impact the high rates of mortality and cardiovascular events among patients with CKD receiving dialysis," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We thank the patients, caregivers and investigators for their participation and engagement in this landmark trial. EVOLVE will provide the nephrology community with important information."

The most frequently reported adverse events in the Sensipar/Mimpara arm of the trial were consistent with the known safety profile of this therapy and included nausea, vomiting and hypocalcemia.

Detailed efficacy and safety analyses from this landmark study are ongoing and will be submitted for presentation at a major medical meeting later this year.

Sensipar/Mimpara is an oral calcimimetic agent approved for the treatment of secondary HPT in patients with CKD receiving dialysis.

EVOLVE Trial Design

EVOLVE was an international, randomized, double-blind, placebo-controlled Phase 3 study of 3,883 patients with secondary HPT and CKD receiving dialysis. The trial, the largest of its kind in patients with CKD receiving dialysis, was designed to determine if treatment with Sensipar/Mimpara, compared to placebo, decreases the risk of all-cause mortality and CV morbidity. The trial consisted of a 30-day screening phase, a titration phase with visits every 2 weeks, and a follow-up phase with visits every 8 weeks. Following the screening phase, patients were randomized to the Sensipar/Mimpara or placebo groups. Possible sequential doses of Sensipar/Mimpara or placebo included 30, 60, 90, 120, and 180 mg. Flexible use of traditional therapies, such as vitamin D derivatives and phosphate binders, were permitted in both groups. 

About Secondary Hyperparathyroidism

Secondary hyperparathyroidism (HPT) is a common and serious condition that is often progressive among patients with CKD and it affects many of the approximately two million people throughout the world who are receiving dialysis. The disorder develops early as an adaptive response to declining kidney function when the parathyroid glands (four small glands in the neck) increase the production of parathyroid hormone (PTH) in an effort to maintain normal levels of calcium and phosphorus. Ultimately, excess PTH production proves inadequate for maintaining normal serum calcium and phosphorous levels. When kidney disease progresses to the point where dialysis is needed to sustain life, secondary HPT manifests as elevated PTH, calcium and phosphorus levels that, in turn, can lead to significant clinical consequences, including bone loss, skeletal fracture, and soft-tissue calcification. Although many patients with secondary HPT are not overtly symptomatic, bone pain, particularly when standing or when walking, achy and stiff joints, muscle weakness, and complaints of dry, itchy skin are common. Advanced disease is marked by very large parathyroid glands that may need to be removed by surgery.

About Sensipar/Mimpara (cinacalcet)

Cinacalcet is approved in more than 50 countries and marketed as Sensipar in the United States (U.S.), Canada, Australia and New Zealand and as Mimpara in the European Union and other countries. Sensipar/Mimpara is the first oral calcimimetic agent approved for the treatment of secondary HPT in CKD patients receiving dialysis. The therapy is also approved by the U.S. Food and Drug Administration, European Medicines Agency and Health Canada for hypercalcemia in patients with parathyroid carcinoma and severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy. Sensipar/Mimpara binds to the calcium-sensing receptor, which causes the receptor to become more sensitive to extracellular calcium ions. This results in a drop in PTH levels by inhibiting PTH synthesis and secretion. In addition, the reductions in PTH lower serum calcium and phosphorus levels.

Secondary HPT Indication
Sensipar is indicated for the treatment of secondary HPT in patients with CKD on dialysis.

Primary HPT Indication
Sensipar is indicated for the treatment of severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy.

Important Safety Information

Sensipar lowers serum calcium; therefore, it is important that patients are carefully monitored for the occurrence of hypocalcemia. Sensipar should not be initiated if serum calcium is less than the lower limit of the normal range. Significant reductions in calcium may lower the threshold for seizures. In the treatment of secondary hyperparathyroidism the most commonly reported side effects in clinical trials were nausea, vomiting, and diarrhea. In the treatment of primary hyperthyroidism, the most commonly reported side effects in clinical trials were nausea, vomiting, and paresthesia.

To see the full Sensipar Safety Information, visit http://pi.amgen.com/united_states/sensipar/sensipar_pi_hcp_english.pdf.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit http://www.amgen.com/. Follow us on http://twitter.com/amgen.

Forward-Looking Statements

This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of June 8, 2012 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative.  Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

CONTACT: Amgen, Thousand Oaks
Christine Regan, 805-447-5476 (media)
Arvind Sood, 805-447-1060 (investors)

(Logo:  http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

SOURCE Amgen

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THOUSAND OAKS, Calif., June 8, 2012 /PRNewswire via COMTEX/ -- Amgen /quotes/zigman/19815/quotes/nls/amgn AMGN -0.33% today announced top-line results of the Phase 3 EVOLVE(TM) (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial, which evaluated Sensipar®/Mimpara® (cinacalcet) for the reduction of the risk of mortality and cardiovascular (CV) events among 3,883 patients with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) receiving dialysis. The primary endpoint of the study was time to the composite event comprising all-cause mortality or first non-fatal cardiovascular event, including myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event. Although patients in the Sensipar/Mimpara arm experienced numerically fewer composite primary events, the results were not statistically significant, and the trial did not meet its primary endpoint in the intent-to-treat analysis.

"Amgen embarked on the EVOLVE trial to understand whether treating secondary HPT with Sensipar/Mimpara could positively impact the high rates of mortality and cardiovascular events among patients with CKD receiving dialysis," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We thank the patients, caregivers and investigators for their participation and engagement in this landmark trial. EVOLVE will provide the nephrology community with important information."

The most frequently reported adverse events in the Sensipar/Mimpara arm of the trial were consistent with the known safety profile of this therapy and included nausea, vomiting and hypocalcemia.

Detailed efficacy and safety analyses from this landmark study are ongoing and will be submitted for presentation at a major medical meeting later this year.

Sensipar/Mimpara is an oral calcimimetic agent approved for the treatment of secondary HPT in patients with CKD receiving dialysis.

EVOLVE Trial Design

EVOLVE was an international, randomized, double-blind, placebo-controlled Phase 3 study of 3,883 patients with secondary HPT and CKD receiving dialysis. The trial, the largest of its kind in patients with CKD receiving dialysis, was designed to determine if treatment with Sensipar/Mimpara, compared to placebo, decreases the risk of all-cause mortality and CV morbidity. The trial consisted of a 30-day screening phase, a titration phase with visits every 2 weeks, and a follow-up phase with visits every 8 weeks. Following the screening phase, patients were randomized to the Sensipar/Mimpara or placebo groups. Possible sequential doses of Sensipar/Mimpara or placebo included 30, 60, 90, 120, and 180 mg. Flexible use of traditional therapies, such as vitamin D derivatives and phosphate binders, were permitted in both groups.

About Secondary Hyperparathyroidism

Secondary hyperparathyroidism (HPT) is a common and serious condition that is often progressive among patients with CKD and it affects many of the approximately two million people throughout the world who are receiving dialysis. The disorder develops early as an adaptive response to declining kidney function when the parathyroid glands (four small glands in the neck) increase the production of parathyroid hormone (PTH) in an effort to maintain normal levels of calcium and phosphorus. Ultimately, excess PTH production proves inadequate for maintaining normal serum calcium and phosphorous levels. When kidney disease progresses to the point where dialysis is needed to sustain life, secondary HPT manifests as elevated PTH, calcium and phosphorus levels that, in turn, can lead to significant clinical consequences, including bone loss, skeletal fracture, and soft-tissue calcification. Although many patients with secondary HPT are not overtly symptomatic, bone pain, particularly when standing or when walking, achy and stiff joints, muscle weakness, and complaints of dry, itchy skin are common. Advanced disease is marked by very large parathyroid glands that may need to be removed by surgery.

About Sensipar/Mimpara (cinacalcet)

Cinacalcet is approved in more than 50 countries and marketed as Sensipar in the United States (U.S.), Canada, Australia and New Zealand and as Mimpara in the European Union and other countries. Sensipar/Mimpara is the first oral calcimimetic agent approved for the treatment of secondary HPT in CKD patients receiving dialysis. The therapy is also approved by the U.S. Food and Drug Administration, European Medicines Agency and Health Canada for hypercalcemia in patients with parathyroid carcinoma and severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy. Sensipar/Mimpara binds to the calcium-sensing receptor, which causes the receptor to become more sensitive to extracellular calcium ions. This results in a drop in PTH levels by inhibiting PTH synthesis and secretion. In addition, the reductions in PTH lower serum calcium and phosphorus levels.

Secondary HPT IndicationSensipar is indicated for the treatment of secondary HPT in patients with CKD on dialysis.

Primary HPT IndicationSensipar is indicated for the treatment of severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy.

Important Safety Information

Sensipar lowers serum calcium; therefore, it is important that patients are carefully monitored for the occurrence of hypocalcemia. Sensipar should not be initiated if serum calcium is less than the lower limit of the normal range. Significant reductions in calcium may lower the threshold for seizures. In the treatment of secondary hyperparathyroidism the most commonly reported side effects in clinical trials were nausea, vomiting, and diarrhea. In the treatment of primary hyperthyroidism, the most commonly reported side effects in clinical trials were nausea, vomiting, and paresthesia.

To see the full Sensipar Safety Information, visit http://pi.amgen.com/united_states/sensipar/sensipar_pi_hcp_english.pdf .

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit http://www.amgen.com/ . Follow us on http://twitter.com/amgen .

Forward-Looking Statements

This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of June 8, 2012 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

CONTACT: Amgen, Thousand OaksChristine Regan, 805-447-5476 (media)Arvind Sood, 805-447-1060 (investors)

SOURCE Amgen

Copyright (C) 2012 PR Newswire. All rights reserved

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It doesn't take a rocket scientist to figure out that the Public Private Partnership (PPP) initiative in Tanzania is booming.

Take a walk around Dar es Salaam and the rest of the country and you are sure to see mushrooming private hospitals, clinics and other forms of health centres. Recently Sanitas, a one stop, state-of-the-art health centre was opened and staff writer Masembe Tambwe explores what this centre will mean to the people of Dar es Salaam and the country at large.

Health sector has proved to be a success in various parts of the country. When one walks around in Dar es Salaam and upcountry, he/she may see a number of hospitals, health centers and dispensaries that have been opened in recent years. Pedro Ramadhani, a dedicated man who used to work as information officer at the Ministry of Health and Social Services died three days after he had revealed some information related to the health sector.

He had revealed that from 1961 to 2011, a total of three zonal hospitals had been opened along with 10 regional hospitals; 86 council designated hospitals owned by religious organisations, 37 district private hospitals, 196 health centers and 2,340 dispensaries. The government using the PPP law is allowed to give subsidies and even medical personnel to private medical establishments so they render services more smoothly to the public.

Mr Ramadhani had said that in recent years, the ministry had seen a mushrooming emergence of diagnostic centers with state of the art technology and other equipment and that the centers were out to assist the government improve medical services as well as increase the number of facilities. One such state of the art facility is Sanitas Medics and Diagnostics Limited whose Chief Executive Officer, Mr Murthy Venkateswaran described it as being the brain child of local and international entrepreneurs who perceived a change in the desires and expectations of Tanzanians for their medical services.

"Sanitas is a modern facility that offers a full suite of outpatient services from consultation, laboratory investigations, surgical solutions, radiology imaging, rehabilitation and physiotherapy, dialysis treatment and a well stocked pharmacy," he said.

Mr Venkateswaran said that the primary goal of the establishment apart from assisting the government and providing quality services to the public was for it to be a one stop center where everything is found under one roof.

He explained that they had spared no effort or expense in creating a spacious modern facility, designed and constructed with patient care in mind. "Ease of access to all services and a central reception reduces the need for patients to be shuffled around. Waiting areas are air conditioned and comfortable with refreshments available. Sanitas' aim is to make world class medical services available to all," he said.

Mr Venkateswaran said with a hint of pride in his voice that in terms of equipment and services, Sanitas is perhaps the first outpatient center that has most of the services one would find in a major hospital. Some of these include five state of the art dialysis units in the latest German technology with their own water purification plant, radiology imaging services (X-ray and Mammogram) that provide a comprehensive range of the latest imaging technology with computer relayed system, and a 3D ultrasound.

There is also a laboratory which is as sophisticated as that of the Muhimbili National Hospital with several pioneering technologies offering the widest range of investigations including hematology, serology, microbiology, immunology, biochemistry, bacteriology and more. Sanitas also houses departments for physiotherapy for gym based rehabilitation and muscle balance, a lifestyle and nutrition consult center, ophthalmology, dentistry, an Ear, Nose and Throat care center, a pediatrics that caters for juvenile diabetes and child obesity among others, a cardiology unit, orthopedic unit and more in the 13 consultation rooms.

"We felt it was important to have as many consultation rooms as possible such that we are able to handle patients swiftly. It is for this reason that we are able to see 500 patients per day," the CEO said. Like many health facilities in the world that have partners, Sanitas has partnered with AMI in Dar es Salaam whereby patients that go to Sanitas and need to be operated upon are taken to AMI for the surgery and hospitalization. The surgeries are done by Sanitas surgeons. This makes Sanitas an OP as well as an IP facility.

It has also partnered with a super specialty hospital based in India with the intention to meeting the government's plans of reducing the number of surgery patients travelling to India by bringing India to Tanzanians. "The number of patients going to India from Tanzania for surgeries has increased significantly to a point where even the Indian institutions are waking up to the potential here. "That and the establishment of Sanitas, which is determined to bring down costs for Tanzanians by bringing the super specialists here have resulted in the frequent visits from specialist surgeons to Dar," he said.

The CEO said Sanitas has an agreement with the Indian Hospital that every four months their super specialist surgeons would come here and operate upon people right here at AMI rather than them having to send patients to India and incur high costs. "Tanzania's big medical problems are to do with the lack of facilities and expertise to perform complex procedures. In time, we at Sanitas will endeavour to address them," he explained.

The installation of five brand new dialysis machines from Fresenius in Germany and staffing of experienced and qualified dialysis technicians in the first week of last month meant that Sanitas being a one stop health center was complete. Recently they started, in support of parents, guardians and caregivers, offering free Well-Child Clinics on the last Saturday of every month from 9am to 12pm.

Led by Dr Alma, sessions cover early nutrition, parenting skills, baby development, feeding techniques, common ailments, hyperactive behavior, developmental monitoring, developmental milestones, cognitive learning, social and emotional skills, and more. From June they have also started a cervical screening center with the appointment of Grace Lubomba, a Cervical Cancer Program Officer. Grace would also be conducting Reproductive and Child Health programs at Sanitas. Sanitas has also recently owned a branch at Quality Plaza along Nyerere Road and will soon open its doors to Arusha residents.

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